Prospective Randomized Clinical Trial for the Management of Uncomplicated Diverticulitis in Right Colon; Non-antibiotics Versus Antibiotics
Overview
- Phase
- Not Applicable
- Intervention
- Cephalosporin + Metronidazole
- Conditions
- Simple Diverticular Disease
- Sponsor
- Dongtan Sacred Heart Hospital
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Treatment Failure
- Last Updated
- 9 years ago
Overview
Brief Summary
The aim of the present study was to evaluate whether antibiotics is mandatory for the treatment of acute uncomplicated right-sided diverticulitis.
The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided colon will be recovered without antibiotics.
Detailed Description
All patients in the study were randomly allocated to one of the following two treatment groups; no-antibiotics group or antibiotics group. Patients of no-antibiotics group were admitted to the ward and administered intravenous fluid and bowel rest at least up to 5 days until clinical symptom and sign were stabilized. And then the patient discharge until oral intake was tolerated. In antibiotics group, the treatment was initiated with an intravenous combination of a third generation cephalosporin or quinolone and metronidazole until oral intake was tolerated. Oral antibiotics such as cefpodoxime together with metronidazole were initiated subsequently on the ward. The total duration of antibiotic treatment was an expected average 10days. Patients in both group were re-visited outpatient clinic after an expected average 7 days for check-up of serology test (including complete blood count and C-reactive protein), and after an expected average 6 weeks for CT. If the patients did not re-visit outpatient clinic, we checked the call.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Right-sided colonic diverticulitis
- •Uncomplicated diverticulitis
Exclusion Criteria
- •Pregnancy
- •Refuse to investigation
- •Immunosuppressive therapy or immunologic incompetence
- •Colonic diverticulitis except right-sided diverticulitis
- •Complicated diverticulitis
- •Disorder of psychology or cognition
- •Allergic reaction to antibiotics being used in the study (3rd generation cephalosporin, quinolone, metronidazole)
Arms & Interventions
Cephalosporin + Metronidazole
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
Intervention: Cephalosporin + Metronidazole
Outcomes
Primary Outcomes
Treatment Failure
Time Frame: 4-6 weeks
advancement or recurrence diverticulitis at the same site.
Secondary Outcomes
- total cost of hospitalization for diverticulitis(up to 2 weeks)
- length of hospital stay at first admission for diverticulitis(up to 2 weeks)